The present invention relates to a container device that is useful for separately storing two ingredients, typically a solid ingredient and a liquid ingredient, and subsequently mixing the two ingredients within the container device. The container device is especially useful for the storage of a solid ingredient that can be degraded during storage, by moisture, and a liquid ingredient wherein, when such ingredients are mixed, the mixture is stable for only a short period of time. For example, a major use of such a container device is for the storage of two intravenous ingredients, eg. a hygroscopic powdered medicament and a liquid diluent. More particularly, the present invention relates to a container device that comprises a flexible bag and an encapsulating container wherein the encapsulating container encapsulates a portion of the flexible bag. The encapsulating container has releasable partitioning means. The releasable partitioning means has three functions: (i) to form a first compartment which comprises the encapsulated portion of the flexible bag, which contains the solid ingredient, and a second compartment which comprises the nonencapsulated portion of the flexible bag, which contains the liquid ingredient; (ii) to seal the encapsulated portion of the flexible bag from the atmosphere external to the encapsulating container; and (iii) to secure the encapsulating container to the flexible bag. Upon release of the releasable partitioning means, the encapsulating container can be removed and the solid ingredient and the liquid ingredient can be mixed.
Container devices that provide separate spaces in a single unit for separately storing two ingredients that can then be mixed within the container device are known. For example, U.S. Pat. Nos. 4,396,383, 3,545,671 and 3,257,072 disclose multi-compartment flexible bags for the storage and subsequent mixing of two liquid ingredients. These designs, perhaps ideal for the storage of two liquid ingredients, may not be suitable when at least one of the ingredients is a solid component that can be degraded by moisture.
Some solid ingredients, such as a hygroscopic medicament, can easily be degraded by moisture when stored in a multi-compartment flexible bag. It is believed that moisture can attack the solid ingredient from three paths. First, moisture from the liquid ingredient can leak through the partition separating the solid ingredient from the liquid ingredient. Second, atmospheric moisture can penetrate the flexible bag. Third, which is somewhat related to the first and second, moisture emanating from the liquid ingredient can penetrate the flexible bag to the atmosphere and then repenetrate the flexible bag where the solid ingredient is stored. The third path is of particular concern if the compartment of the flexible bag that contains the solid ingredient and the compartment of the flexible bag that contains the liquid ingredient are stored in the same container or are in contact with each other during storage.
The liability of utilizing a multicompartment flexible bag to store a solid ingredient is appreciated in the art. U.S. Pat. No. 4,467,588 discloses a container system for separately storing a sterilized powder and a sterilized liquid in a container device. The container system includes two sealed chambers having a sterilized frangible connection therebetween, one said chamber containing the liquid ingredient and the other said chamber including a sealed vial containing a solid ingredient. A similar container device, which is used for the storage of a powdered medicament and a liquid diluent, is being marketed by Abbott Laboratories under the tradename ADD Vantage.
These devices, although perhaps rendering stability to the solid ingredient, have many drawbacks. One drawback is that such devices have numerous components, many of which must be sterilized. The vial, the flexible bag and all the components connecting them must be sterilized. Sterilization, especially the maintenance of sterility of each component during the period of time that the solid ingredient and liquid ingredient are being placed in the container, is very expensive. Another drawback is that at the joints connecting the vial and flexible bag there is the opportunity for microbial attack, which may result in the end user getting an infection. Yet another drawback is that in order to mix the contents of the vial and flexible bag, a frangible connector must be broken. This results in a portion of the frangible connector being placed in the flexible bag. The patient receiving the solution may find this disturbing. Also, during mixing, some of the solid ingredient can get caught in the joints connecting the vial and flexible bag. Not only is such solid ingredient wasted, but also this may render the entire mixture useless. Yet another drawback is that when such container device is being utilized, the vial is present. In view of that the vial is typically glass, there exists the possibility that it can break. Still another drawback is that someone other than the manufacturer will typically connect the vial and flexible bag. Thus, there is the possibility that one may connect the wrong vial and flexible bag.
Accordingly, there is the need for a container device that can separately store a solid ingredient and liquid ingredient without the solid ingredient being degraded during storage and yet, such two ingredients can be mixed easily in the container device and not have the drawbacks described hereinabove.